At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- GL-2045 (drug)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- GL-2045 — drug: Administrative route: SC injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 42
- Started
- 2026-04-14
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for immune thrombocytopenia
- • Phase1 - 42 participants
- • The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP)
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with immune thrombocytopenia
Where?
- • Leeds - Fortrea Clinical Research Unit Ltd
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
More detail
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine: * The safety of the study drug when given to participants with ITP * The effect of the study drug on safety blood tests and blood platelet counts * How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life * How much of the study drug gets into the bloodstream * The body's immune response to the study drug This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.
- ✓Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.
- ✓A blood clotting cell count of 10 to 49 × 10\^9/L at baseline.
Who cannot take part
- ✗Any serious adverse event (SAE) with prior IVIg dosing.
- ✗Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.
- ✗Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to...
- ✗Abnormal organ health including liver and kidney.
- ✗Any previous or current treatments prohibited by the protocol.
See the full criteria
Where Is This Study? (1 UK site)
Fortrea Clinical Research Unit Ltd
Leeds LS11 9EH, United Kingdom
How to Get in Touch
Gliknik Clinical Trials Group
Sponsor contactCONTACT